The following data is part of a premarket notification filed by Concord/portex with the FDA for New-vent.
Device ID | K911809 |
510k Number | K911809 |
Device Name: | NEW-VENT |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
Contact | Robert Wheeler |
Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-23 |
Decision Date | 1991-08-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NEW-VENT 72149923 0754175 Dead/Expired |
DOVER CORPORATION 1962-07-27 |